The FDA has approved a twice-a-day formulation of Ferriprox® (deferiprone; Chiesi) for the treatment of transfusional iron overload due to thalassemia syndromes when current chelation therapy is inadequate.
The FDA has granted Priority Review for the Biologics License Application (BLA) for sutimlimab for the treatment of hemolysis in adult patients with cold agglutinin disease, a rare type of autoimmune hemolytic anemia.
The studies compared the efficacy and safety of vadadustat to darbepoetin alfa in adult patients on dialysis with anemia due to CKD.
The FDA has approved Reblozyl® (luspatercept–aamt; Bristol-Myers Squibb and Acceleron) for the treatment of anemia in adults with lower-risk myelodysplastic syndromes.
The FDA has approved the New Drug Application for Triferic AVNU®.
Among those with baseline anemia, hemoglobin levels improved with canakinumab versus placebo
The FDA has accepted for review the New Drug Application (NDA) for roxadustat (FibroGen) for the treatment of anemia of chronic kidney disease (CKD) in both nondialysis-dependent and dialysis-dependent patients.
Monoferric will be supplied in 100mg/mL, 500mg/5mL, and 1000mg/10mL single-dose vials for intravenous infusion after dilution.
Visit our New Drug Products page to stay up-to-date on the latest hematology drug approvals.
This slideshow gives you an at-glance view of all the new drug approvals in 2019. For the latest drug approvals visit our New Drug Products page.
